There should be no mistake iovera is an unbelievably important and really valuable asset for us going forward.
Operator: Thank you very much for your questions. One moment, please. Our next question is from Gregory Renza with RBC Capital Markets.
Q – Unidentified Analyst: Good morning, Dave It’s Anish on for Greg. Thanks so much for taking the questions. Firstly, I just wanted to ask on the lower extremity nerve block expansion opportunity with the upcoming PDUFA, how should we be thinking about labeling? And second, if you would share an early assessment on the 340B strategy progress to date and expectations ahead? Thanks again.
Dave Stack: Yes. Thank you, Anish. The lower extremity nerve block, we believe — well, first of all, the data is strong as any that we’ve ever had for EXPAREL. And then really importantly, it’s a superiority label against bupivacaine. So this is data where these P values in some cases, 0.0001. for opioid reduction and pain control are compared to bupivacaine. So an important aspect that I’m not sure everyone understands. And we have 96 hours of pain control four days with a 10 ml dose. So we think that we address the — at least start to address the pain are the opportunity to use a lower extremity nerve block with a price that is very appropriate for the four days of pain control, and we think that starts to address the cost issue as well.
So we’re really excited about the lower extremity nerve block we expect that the PDUFA date is in play here, and we’re looking forward to the next couple of weeks and moving ahead on that. In terms of the early assessment of 340B, it’s done exactly what it was supposed to do in terms of patient growth in the 340B environment to the point where, especially in the first half of this year, the impact of 340B was greater than we had anticipated that it would be when we put the program into play. So what we’ve seen in the second half of the year with some growth in the nonparticipating accounts, the accounts that are new to EXPAREL as a result of 340B as well as understanding that we got the price increase from early in the year took effect for 340B in July.
We see that, that number comes back to something that’s much closer to the 20% discount that we anticipated in the first place relative to EXPAREL specifically. So it’s doing what it’s supposed to do. We will look at 340B again when we have no pain as we come up on no pain. One of the things that will be really important for us to do is see if replacing a 24% statutory discount with full reimbursement at ASP plus six really allows us to look only at the places where there may be certain patient populations that fall out of 340B that won’t be picked up and no pain. And we want to make sure that we have strategies to address those patient populations. Other than that, in terms of maintaining access and building the pool for no pain going forward, 340B is doing what it was supposed to do.
Thanks, Anish.
Q – Unidentified Analyst: Thank you.
Operator: Thank you for your questions. Our next question is from Balaji Prasad from Barclays. Your line is open.
Unidentified Analyst: Hey, good morning. This is Shao on Bajali and thanks for taking our questions. Just a quick follow-up on 340B. So EXPAREL volume growth, can you give us a bit of dynamics of what portion of that growth was from 340B — and what portion of the growth was from existing channels? Thank you.
